Further study details as provided by Centre for the AIDS Programme of Research in South Africa:

Primary Outcome Measures:

Mean number of returned used applicators [ Time Frame: monthly ] [ Designated as safety issue: Yes ]

Gel use is essential for the effectiveness of tenofovir gel in preventing HIV infection. The level of gel use was a strong predictor of effectiveness in the exploratory adherence analysis of the CAPRISA 004 trial. Gel use on its own and in relation to coitus were both predictors of the level of protection. Based on the CAPRISA 004 trial which demonstrated a correlation between the number of returned used applicators and the level of effectiveness against HIV infection, the primary endpoint is:

Participants will be randomized to receive 1% tenofovir gel through either:

Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or

The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm).

Detailed Description:

The CAPRISA 008 trial is a two-arm, open-label, randomized controlled trial that is being conducted at the CAPRISA eThekwini and CAPRISA Vulindlela Clinics and their neighboring public sector family planning services in KwaZulu-Natal, South Africa. Up to 700 consenting sexually active, HIV-uninfected women aged 18 years and older who previously participated in an antiretroviral (ARV) prevention study will be enrolled and followed for a maximum 30 months. All women will be provided with 1% tenofovir gel but will be randomised to either receive their gel through a public sector family planning services with 2-3 monthly provision (intervention arm) or through the CAPRISA research clinics with monthly provision (control arm).

All women in the trial will be provided with the standard package of HIV prevention and reproductive health services. Participants in both study arms will be provided with a supply of single-use, pre-filled applicators of 1% tenofovir gel. While in the study, participants will be advised and supported to follow the CAPRISA 004 pre- and post-dosing strategy, namely BAT24, where the first dose of tenofovir gel is applied within 12 hours before anticipated coitus and a second dose as soon as possible but within 12 hours after coitus, with a maximum of two doses of gel in a 24-hour period.

The primary objective of this trial is to assess the effectiveness of an implementation model for tenofovir gel provision through family planning services.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Age 18 years and older

Women who previously participated in an ARV prevention study

Currently utilizing or agreeing to attend designated public sector family planning services

Able and willing to provide first person informed consent to be screened for, and to enroll in, the study

Able and willing to provide adequate locator information for study retention purposes

Sexually active (at least one coital act in the last 3 months prior to screening)

HIV negative (by HIV testing performed by study staff within 30 days of enrollment)

Negative pregnancy test performed by study staff within 21 days of enrollment

Agree to use a non-barrier form of contraceptive

Agree to adhere to study visits and procedures

Exclusion Criteria:

Has a creatinine clearance < 50ml/min

Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691768